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NCT Number: NCT06876415

Free for Weaning ECMO vs Respiratory Driven Study

In its most severe form, Acute Respiratory Distress Syndrome (ARDS) may require the use of veno-venous ECMO (vvECMO). While the criteria for vvECMO indication, ECMO settings, and ventilator management are relatively well-defined after the publication of the EOLIA trial and subsequent national or international guidelines, few studies have assessed the criteria and methods for weaning from vvECMO. Besides, advances in the understanding of the pathophysiology of mechanical ventilation (MV) weaning process have led to the development of specific monitoring tools for this phase.

Schematically, respiratory drive can be evaluated via the ventilator by measuring the pressure generated during a 100-millisecond expiratory occlusion (P0.1) and respiratory efforts through the measurement of esophageal pressure variation (delta Poeso).

Recent retrospective studies conducted on COVID-19 ARDS patients supported by vvECMO suggest a longer duration of mechanical ventilation for patients whose weaning and decannulation process was "forced," i.e., performed under conditions of significant respiratory drive and effort. High values of P0.1 and delta Poeso were associated with prolonged MV duration. Self-inflicted lung injury (P-SILI) and elevated transpulmonary pressure related to these uncontrolled respiratory efforts likely explain the negative impact on MV duration.

Therefore, this randomized study proposes to assess these monitoring tools, which are regularly used in clinical practice, to guide vvECMO weaning and decannulation decisions.

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Key information

Conditions

ARDS (Acute Respiratory Distress Syndrome) Acute Lung Injury Lung Diseases Lung Injury Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospices Civiles de Lyon, Lyon, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients aged 18 years or older Patient whose trusted person has given consent for participation in the study
  • Patient on veno-venous ECMO with weaning criteria, including:
  • Resolution of the cause of ARDS
  • Absence of hemodynamic instability, defined as norepinephrine dose ≤ 0.5 μg/kg/min for at least 3 hours
  • Use of a ventilatory mode that allows spontaneous ventilation (VS-AI, BiPAP, or APRV)
  • Maximum inspiratory pressure ≤ 28 cm H2O, with a maximum driving pressure ≤ 15 cm H2O, enabling tidal volumes between 4 and 8 ml/kg of predicted body weight (PBW)
  • ECMO membrane sweep flow ≤ 2 L/min
  • Patient protected by social security

Exclusion criteria

  • Contraindication to the placement of an esophageal pressure balloon (e.g., esophageal varices, nasal trauma, uncontrolled coagulopathy, severe thrombocytopenia),
  • Patient with treatment limitation at the time of inclusion,
  • Patient in the time frame of exclusion from another research protocol at the time of consent signing,
  • Vulnerable patients: minor, adult patient under guardianship or curatorship, patient deprived of liberty, pregnant or breastfeeding woman.

Treatment and study plan

P0.1 and delta Poeso integration into the decanulation decision

Other

P0.1 and delta Poeso integration into the decanulation decision

Primary outcomes

  1. Duration of mechanical ventilation from ECMO decannulation to weaning from mechanical ventilation

    Time frame: 60 days after inclusion

    The weaning from mechanical ventilation is defined as the absence of mechanical ventilation for 48 consecutive hours.

  2. P0.1 and delta Poeso measurements

    Time frame: From inclusion to 48h after decanulation

    P0.1 and delta Poeso values will be monitored and tracked at inclusion and then every 8 hours until decannulation, and up to 48 hours after decannulation.

    In the experimental group, these values will be incorporated into the criteria guiding the decannulation decision.

    In the control group, these values will be monitored and recorded by an investigator who is not involved in the decannulation decision. These values will not be included in the criteria guiding the decannulation decision.

Secondary outcomes

  1. Mortality rate in intensive care unit

    Time frame: 60 days after inclusion

  2. Mortality rate in hospital

    Time frame: 60 days after inclusion

  3. Intensive care unit stay duration from inclusion

    Time frame: 60 days after inclusion

  4. Hospital stay duration from inclusion

    Time frame: 60 days after inclusion

  5. Total number of days spent on ECMO from admission to intensive care unit discharge

    Time frame: 60 days after inclusion

  6. Total duration of mechanical ventilation

    Time frame: 60 days after inclusion

  7. Time between the start of mechanical ventilation and ECMO cannulation

    Time frame: 60 days after inclusion

  8. Number of ventilator-free days

    Time frame: 60 days after inclusion

  9. Number of patients decannulated and then re-initiated on vvECMO

    Time frame: 60 days after inclusion

  10. Number of patients requiring controlled ventilation for at least 24 hours after decannulation

    Time frame: 60 days after inclusion

  11. Number of days with continuous sedation with or without continuous paralysis after decannulation

    Time frame: 60 days after inclusion

  12. Incidence of barotrauma assessed by radiographs and clinical examination after decannulation

    Time frame: 60 days after inclusion

  13. Percentage of patients placed in prone positioning after decannulation

    Time frame: 60 days after inclusion

  14. Number of days on inhaled nitric oxide after decannulation

    Time frame: 60 days after inclusion

  15. Neuromyopathy on the day of decannulation

    Time frame: Day of decanulation

    Neuromyopathy will be assessed using the Medical Research Council score. Total score ranges from 0 (complete tetraplegia) to 60 (normal muscle strength).

  16. Neuromyopathy on the day of weaning from mechanical ventilation

    Time frame: Day of weaning from mechanical ventilation

    Neuromyopathy will be assessed using the Medical Research Council score. Total score ranges from 0 (complete tetraplegia) to 60 (normal muscle strength).

  17. Number of patients who received corticosteroid therapy

    Time frame: 60 days after inclusion

    ≥ 0.5 mg/kg of equivalent methylprednisolone

Study contacts

Contact information is provided by the study sponsor or research team.

Christophe GUERVILLY, M.D.

CONTACT

[email protected]

04 91 96 58 35 ext. +33

Sami HRAIECH, M.D., Ph.D

CONTACT

[email protected]

04 91 96 58 35 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study title

Monitoring of Occlusion Pressure and Esophageal Pressure to Guide Weaning From Venovenous ECMO in ARDS: a Randomized Controlled Study

Acronym: FORWARD

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 14, 2025
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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